FDA Adverse Event Malfunction Summary report: N

INTELLIVUE

MDR report key: 11398813 · Received March 2, 2021

Report

Report Number
11398813
Event Type
Malfunction
Date Received
March 2, 2021
Date of Event
January 29, 2021
Report Date
February 1, 2021
Manufacturer
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
Product Code
MWI
Product Problem
Yes
Report Source
User Facility report
Reporter Location
ND
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

COMPUTER SCREEN LABELED TELE 1 BEGAN TO FREEZE AND THEN CRASH/RESTART WHEN TRYING TO VIEW A PATIENT'S CARDIAC REVIEW. AFFECTED FLOORS, BIOMED, AND MANAGER WERE NOTIFIED. BIOMED HELPED TROUBLESHOOT REMOTELY AND OVER THE PHONE. TRIED PUTTING THE PATIENT ON TELE 2 AND ACCESSING CARDIAC REVIEW. THAT CAUSED TELE 2 TO FREEZE THEN CRASH. AFFECTED FLOORS AND BIOMED WERE NOTIFIED. TELE 1 AND TELE 2 ENDED UP BEING REBOOTED AND THE ISSUE WAS RESOLVED AROUND 08:30 AM. AFFECTED FLOORS, BIOMED, AND MANAGER NOTIFIED. MANUFACTURER RESPONSE FOR PIIC IX SERVER, PHILIPS MEDICAL (PER SITE REPORTER): THE TELE WAS LOCKING UP AND I WENT AND DID A PIIC REBOOT AND THE PROBLEM SEEMED TO GO AWAY. STAFF MEMBER SAID LET ME KNOW IF IT DOES IT AGAIN WHEN I GO INTO THIS PATIENTS WAVE REVIEW, SHE DID THAT AND SHORTLY DURING THAT IT LOCKED UP AGAIN. WE TRIED DISCHARGING THE PATIENT AND RE-ADMIT BUT THAT DID NOT SOLVE IT. WE THEN REMOVED IT FROM TELE 1 TO TELE 2, BUT THE TELE 2 SCREEN ALSO LOCKED UP. THEY ARE BOTH LOCKING UP. CALLED PHILIPS TECH SUPPORT- THEY THEN CONNECTED US TO A FIELD SERVICE ENGINEER. HE WAS ABLE TO LOG ONTO OUR SYSTEM AND SEE THAT THE 2 PIICS WERE HAVING ISSUES. HE HAS SEEN THIS BEFORE SO HE - RE DID SYSTEM SET UP ON BOTH PIICS. AFTER COMPLETION WE TESTED ALL THE WAVE REVIEWS ON BOTH TELE 1 AND TELE 2. NO PROBLEMS FOUND UNIT IS BACK UP AND WORKING PER THE TECHS. THE SERVICE ENGINEER WAS GOING TO KEEP THE CASE NUMBER OPEN BECAUSE IF IT WERE TO COME BACK THEN WE WOULD NEED TO LOOK AT THE PHYSIO SERVER AND THAT WOULD INVOLVE A PHILIPS REP TO COME IN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
295568 INTELLIVUE MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MWI PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV PIIC IX

Patients

Seq Age Sex Outcome Treatment
1